Convergence of EHR and EDC

By Mark D. Uehling

Dec 2005 / Jan 2006 | At a doctor’s office in Tennessee, applications from Allscripts and Advanced Clinical Software allow physicians to streamline their record keeping. The twist? The same electronic health record (EHR) systems that made billing and patient care more efficient are used to manage data for clinical trials.

“They were able to generate three times the amount of revenue just because they didn’t have to manually review charts,” notes Steve Schwartz, Allscripts’ senior VP of corporate development. As a result of the new clinical trial revenue, the ledger of the Tennessee practice went from red to black.

As evidenced by a recent conference* on merging EHR and EDC (electronic data capture), the hypothesized convergence of applications and databases for drug development, clinical trials, hospitals, and physicians is both closer and more distant. That integration is already happening in selected projects. But long-term synergy requires adherence to CDISC and HL7 data standards that is absent within life science organizations and hospitals, much less across regions.

Promise and DangerMichael Barrett of Critical Mass Consulting has watched the lurching of EDC vendors and the EHR trade for years. “This is the first ever meeting to discuss the convergence of these two technologies,” Barrett said.

Barrett noted there are people in the clinical trial vendor community who believe the difficulty of EDC is grossly underappreciated by EHR vendors. Is EDC brain surgery? Those at the meeting did not agree. But there is a wild disparity between tiny, struggling EDC firms and the likes of EHR players such as GE Healthcare, Cerner, and Epic Systems.

At the same time, most physician-office and hospital data resides in EHR systems that are not 21 CFR Part 11 compliant. Ordinary patient data is often unprotected by audit trails and rife with errors, jargon, and other flotsam that would appall the FDA. Just integrating handwritten patient records, not to mention dictated physician notes, will be arduous.

Columbia University’s Stan Kachnowski noted with some bemusement that the main U.S. evangelist for EHRs, David Brailer, national coordinator for health-IT, has a mere $15 million to work with. Meanwhile, in the United Kingdom, the budget for a nationwide, 10-year project is $6 billion.

Kachnowski warned that EHR can inflict misery on ordinary physicians. “We’re asking physicians to record their lives electronically in ways that are unprecedented historically,” said Kachnowski. “Never before have we asked anyone to record their day on a minute-to-minute basis.”

Hugh Donovan, general manager of clinical trials business at Siemens Medical Solutions, said that after a dormant 2003 partnership between Siemens and EDC firm eResearchTechnology, he now hopes to work with other EDC firms: “You can’t have exclusive relationships with EDC vendors.”

Donovan seemed tired of the naysayers. “It is too easy for a group of people to sit around and pick holes,” said Donovan. “We have to get out there and do it and see what happens.” Siemens already has a Munich pilot project and hopes to be able to present a variety of metrics in 2006. EHRs may contain 40 percent of the data needed in a clinical trial.

That statistic, if validated, could spur partnerships between organizations specializing in EHRs and EDC. The prospect of a mother lode of patients eligible for clinical trials was alluring to many at the meeting.

Could Pharma Fund EHRs?Somesh Nigam, enterprise architect at Johnson & Johnson, wondered about a doctor in community practice: “Can you find patients in your own practice with inclusion-exclusion criteria and identify them rapidly? This is a great opportunity.” His comment suggested that the pharmaceutical industry could help finance the adoption of EDC-enabled EHRs. The record shows that the legality of such investments is open to dispute.

So is the political risk. Michael Barrett dubbed this “the freak-out factor.” That’s the chance that any hospital considering a partnership with pharma would worry about hostile media attention — and might not forge partnerships creating beguiling EHR-EDC systems in the first place.